applying for GMP LIcense in AyurvedaGmp

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  • 7/29/2019 applying for GMP LIcense in AyurvedaGmp

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    VIPASHA PHARMACEUTICALS8- Industrial Area, Shamshi- 175 126

    The Valley of Gods, Distt. Kullu (HP)

    GOOD MANUFACTURING PRACTICES

    BEING ADOPTED IN

    VIPASHA PHARMACEUTICALS

    8- INDUSTRIAL AREA, SHAMSHI 175 126

    DISTRICT KULLU (HP)

    FACTORY PREMISES

    Sr. No. Particulars Specifications in

    Mtrs.

    Specifications in fts.

    1. Factory Shed 10.10x20.00

    2. StoresRaw Material Godown 7.00x4.10

    Finished Goods Godown 7.00x4.10

    3. Administrative Block 4.00x3.00

    4. Workers Retiring Room 5.00x4.00

    The premises of the factory are clean and hygienic and are free from cobwebs, insects,

    rodents atc.

    The premise is not situated adjacent to any open sewage, drain, public lavatory or anyfactory, which produces obnoxious odour or large quantities of soot, dust or smoke.

    The walls of the rooms are impervious to water and are capable of being kept clean.

    Walls in the manufacturing area are oil-painted.The flooring is smooth and even and is such as not to permit retention or accumulation of

    dust or waste products.

    The building is such that does not give ingress to rodents, insects, reptiles etc., as thebuilding has double windows and double doors, wherever needed.

    The factory has adequate provision for light and ventilation.

    The water used in the manufacturing is of drinkable quality, free from pathogenic

    organisms.Adequate provision of good water for washing the premises exists.

    The sanitary fittings and electrical fixtures are proper and safe.

    Adequate arrangement exists for washing, cleaning and drying of packing containers.

    Underground drainage system exists for disposal of waste- water and other residues fromthe manufacturing premises.

    The furnace/Bhatti section is separate and is such as to prevent ingress of flies or dust.Fire safety measures duly exist.

    Weight and measuring equipment is periodically/ regularly inspected by the authorities.

    The factory and its manufacturing processes are non-polluting.

    All workers are medically examined periodically for any contagious disease. All workersare provided with clean aprons, suitable for the nature of work. Suitable facilities for

    personal cleanliness, such as clean towels, soap etc. is provided for the workers. Separate

    provision for drinking water, washing and lavatories is provided at the retiring rooms,away from manufacturing area.

    (PROPRIETOR)

  • 7/29/2019 applying for GMP LIcense in AyurvedaGmp

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    VIPASHA PHARMACEUTICALS

    8- Industrial Area, Shamshi- 175 126The Valley of Gods, Distt. Kullu (HP)

    VPQ / 3955/ 02-03

    Dated: 10/07/2002

    To

    The Director of Ayurveda,

    Directorate of Indian System of Medicine & Homoeopathy,

    Himachal Pradesh,

    Kasumpti, Shimla -9.

    SUBJECT: Request for the issue of GMP Certificate for our Unit.

    REFERENCE: Your office letter No. Ayu.H (A)(3) -9/ 85-II- 5235-5325, dt. 21/03/02.

    Sir,

    I shall feel obliged if you kindly, get our unit inspected, as per regulations, and

    award us the required GMP Certificate, on Form 26E 1.

    It may be stated here that our unit is adhering to all the good manufacturing

    practices as were prevalent, since long, as is evident in our previous communications

    with the department, even prior to the guidelines framed by the Central Govt.

    I am enclosing herewith a gist of the parameters already adopted by us, apart from

    the older Schedule T of the Drugs Act, 1940, as amended from time to time.

    Thanking you and awaiting your benevolent action in the matter at the earliest.

    Yours truly,

    For Vipasha Pharmaceuticals,

    PROPRIETOR Enclrs: as above.